The following data is part of a premarket notification filed by Stryker Corp. with the FDA for Hoffmann 3 Modular External Fixation System.
Device ID | K111786 |
510k Number | K111786 |
Device Name: | HOFFMANN 3 MODULAR EXTERNAL FIXATION SYSTEM |
Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
Applicant | STRYKER CORP. 325 Corporate Drive Mahwah, NJ 07430 |
Contact | Estela Celi |
Correspondent | Estela Celi STRYKER CORP. 325 Corporate Drive Mahwah, NJ 07430 |
Product Code | KTT |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-06-24 |
Decision Date | 2012-01-26 |
Summary: | summary |